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Axsome says FDA accepts AXS-12 narcolepsy cataplexy NDA, sets May 1, 2027 PDUFA date
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Axsome says FDA accepts AXS-12 narcolepsy cataplexy NDA, sets May 1, 2027 PDUFA date
  • Axsome Therapeutics’ NDA for AXS-12 (reboxetine) to treat cataplexy in narcolepsy was accepted for FDA review.
  • The FDA set a PDUFA target action date of May 1, 2027.
  • The agency does not currently plan to convene an advisory committee meeting for the application.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Axsome Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607150700PRIMZONEFULLFEED9762470) on July 15, 2026, and is solely responsible for the information contained therein.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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